ATTACHMENT 1 - QUALITY ASSURANCE SURVEILLANCE PLAN.docx
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- Solicitation number
- 36C24926Q0380
About this file
This is a Quality Assurance Surveillance Plan (QASP) for Medical Physicist services at the James H. Quillen VA Medical Center in Mountain Home, Tennessee under solicitation 36C24926Q0380. The QASP outlines the Government's systematic approach to evaluating contractor performance across ten key performance measures aligned with radiotherapy practice standards established by the American College of Radiology (ACR), American Society for Radiation Oncology (ASTRO), and American Association of Physicists in Medicine (AAPM).
The plan establishes performance standards for qualifications and availability of key personnel (100% board certification and availability requirement), development and maintenance of Standard Operating Procedures for all radiotherapy techniques with annual updates (90% acceptable quality level), current licensing and certifications (100%), mandatory training completion (100%), privacy and HIPAA compliance with zero tolerance for breaches (100%), professional conduct with zero complaints threshold (95%), patient documentation and electronic signing within 24 hours (95%), Quality Assurance/Quality Improvement documentation per practice guidelines with quarterly reporting (90-100% depending on standard), and radiation safety program compliance with quarterly reporting to the Radiation Safety Committee (100%). Surveillance methods include direct observation of 100% of cases by the Chief Radiation Oncologist, periodic quarterly inspections, validated user complaints, random sampling, and contractor-provided documentation. The Contracting Officer is Olonzo Haynes and the Contracting Officer's Representative is Jason Dubay. Performance ratings range from Exceptional to Unsatisfactory, with the COR providing quarterly written reports to the CO. Contract Discrepancy Reports (CDRs) will be issued for unacceptable performance, requiring corrective action plans from the contractor.
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Other files
| File | Type | Posted |
|---|---|---|
| 36C24926Q0380 0002.docx | DOCX document | |
| 36C24926Q0380 0001.docx | DOCX document | |
| ATTACHMENT 2 - CONTRACTOR CERTIFICATION IMMIGRATION AND NATIONALITY ACT OF 1952 AS AMENDED.docx | DOCX document | |
| 36C24926Q0380.docx | DOCX document | |
| ATTACHMENT 3 - CONFLICT OF INTEREST CERTIFICATION STATEMENT.docx | DOCX document |
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ATTACHMENT 1 – QUALITY ASSURANCE SURVEILLANCE PLAN
The contractor will be evaluated in accordance with the following:
1. PURPOSE
This Quality Assurance Surveillance Plan (QASP) provides a systematic method to evaluate performance for the stated contract. This QASP explains the following:
· What will be monitored?
· How monitoring will take place.
· Who will conduct the monitoring?
· How monitoring efforts and results will be documented.
This QASP does not detail how the contractor accomplishes the work. Rather, the QASP is created with the premise that the contractor is responsible for management and quality control actions to meet the terms of the contract. It is the Government’s responsibility to be objective, fair, and consistent in evaluating performance.
This QASP is a “living document” and the Government may review and revise it on a regular basis. However, the Government shall coordinate changes with the contractor through contract modification. Copies of the original QASP and revisions shall be provided to the contractor and Government officials implementing surveillance activities.
2. GOVERNMENT ROLES AND RESPONSIBILITIES
The following personnel shall oversee and coordinate surveillance activities.
a. Contracting Officer (CO) – The CO shall ensure performance of all necessary actions for effective contracting, ensure compliance with the contract terms, and shall safeguard the interests of the United States in the contractual relationship. The CO shall also assure that the contractor receives impartial, fair, and equitable treatment under this contract. The CO is ultimately responsible for the final determination of the adequacy of the contractor’s performance.
Assigned CO: Olonzo Haynes; Olonzo.haynes@va.gov Assigned CS: Rebecca Espinoza; Rebecca.espinoza@va.gov Organization or Agency:
b. Contracting Officer’s Representative (COR) – The COR is responsible for technical administration of the contract and shall assure proper Government surveillance of the contractor’s performance. The COR shall keep a quality assurance file. The COR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government’s behalf.
Assigned COR: Jason Dubay Organization or Agency: Mountain Home VA Medical Center
3. CONTRACTOR REPRESENTATIVES
The following employee(s) of the contractor serve as the contractor’s program manager(s) for this contract.
Primary:
Alternate:
4. PERFORMANCE STANDARDS
The contractor is responsible for performance of ALL terms and conditions of the contract. CORs will provide contract progress reports quarterly to the CO reflecting performance on this plan and all other aspects of the resultant contract. The performance standards outlined in this QASP shall be used to determine the level of contractor performance in the elements defined. Performance standards define desired services. The Government performs surveillance to determine the level of Contractor performance to these standards.
The Performance Requirements are listed below in Section 6. The Government shall use these standards to determine contractor performance and shall compare contractor performance to the standard and assign a rating. At the end of the performance period, these ratings will be used, in part, to establish the past performance of the contractor on the contract.
5. INCENTIVES/DEDUCTS
The Government shall use past performance as incentives. Incentives shall be based on ratings received on the performance standards (Inclusion of any monetary incentives requires approval through the Department’s Senior Procurement Executive (SPE).
6. METHODS OF QA SURVEILLANCE
Various methods exist to monitor performance. The COR shall use the surveillance methods listed below in the administration of this QASP.
a. DIRECT OBSERVATION. 100% surveillance: All cases will be reviewed by Chief Radiation Oncologist at Mountain Home VA Medical Center.
b. PERIODIC INSPECTION. Inspections scheduled and reported quarterly per COR delegation or as needed. All patient files will be reviewed per inspection period. All inspections and reports will be conducted in compliance with VA Privacy and Information security standards.)
c. VALIDATED USER/CUSTOMER COMPLAINTS.
d. RANDOM SAMPLING.
e. Verification and/or documentation provided by Contractor.
36C249Q0380 Medical Physicist
PERFORMANCE MEASURES
| Measure |
| PWS |
Para.
Performance Requirement
| Standard |
| Acceptable Quality Level |
| Surveillance |
Method
Qualifications and Availability of Key Personnel
| 4.6.1 |
| Radiation Oncology Physicians, Therapeutic Medical Physicists, Dosimetrists shall be board certified and in accordance with national recognized accrediting body standards; Therapeutic Radiologic Therapists shall be registered & certified through the American Registry of Radiologic Technologists. The Contractor shall provide evidence that workload is distributed between 2 or more providers within the group and that treatment is provided in compliance within standard of care outlined in this PWS. |
| 100%; Radiation Oncology Physicians, Therapeutic Medical Physicists, Dosimetrists shall be board certified and in accordance with national recognized accrediting body standards; Therapeutic Radiologic Therapists shall be registered & certified through the American Registry of Radiologic Technologists, and available to provide the required scheduled services to veterans 100% of the time. |
| 100% |
| Periodic Sampling of qualification documentation and medical records submitted in accordance with contractor reporting requirements |
| Standard Operating Procedures (SOP) for all radiotherapy techniques |
| 4..6.2 |
| All (100%) of radiotherapy techniques employed by the Contractor, such as Conventional External Beam, IMRT, IGRT, SBRT, SRS, Brachytherapy (edit per the PWS and services available), etc., have written procedures in accordance with radiotherapy practice standards. All (100%) of procedures are reviewed and updated annually. |
| 100% of procedures are documented and reviewed and updated annually. |
| 90% |
| Random Sampling of procedure documentation and medical records submitted in accordance with facility reporting requirements. |
| Maintains licensing, registration, and certifications |
| 4.6.3. |
| Updated Licensing, registration and certifications will be provided as they are renewed. |
| 100% Licensing registration information kept current. |
| 100% |
Random Sampling and Periodic Inspection
| Mandatory Training |
| 4.6.4. |
| Contractor completes all mandatory required training |
| All Training (100%) completed as required per VAMC policy |
| 100% |
| Contractor to provide documented evidence |
Privacy Confidentiality and HIPPA
| 4.6.5. |
| Contractor is aware of all laws, regulations, policies, and procedures relating to Privacy, Confidentiality and HIPPA and complies with all standards |
| Zero breaches of privacy or confidentiality |
| 100% |
Contractor to provide evidence of annual training required by VAMC, reports violations per policy
| Professionalism/Conduct |
| 4.6.6 |
| Contractor employees maintain excellent relationships with patients, Radiation Oncology staff members, VA Medical Center staff members, and vendors. |
| Zero complaints from VA Medical Center staff members related to the contractor’s employee interfering with patient care or the ordinary operation of the facility. |
| 95% |
| COR notification of complaints |
Patient Reports and Documentation
| 4.6.7. |
| All notes must be electronically signed, and all encounters closed within 24 hrs. |
| Compliance with VA Rules and Regulations |
| 95% |
| Periodic Inspection and Random Sampling |
| Quality Assurance/ Quality Improvement (QA/QI) Documentation Performance Requirement |
| 4.6.8. |
| The contactor shall have an operation performance improvement process in accordance with practice guidelines and standards promulgated by ACR, ASTRO, and AAPM, including data collection, measurement, assessment, and improvement. Data shall be required on processes, outcomes, patient satisfaction, and quality control. Appropriate statistical quality control techniques in compliance with relevant radiotherapy practice standards must be utilized. Results of performance improvement activities must be reported quarterly to the VA Radiation Oncology Service Quality Assurance Committee. Reviewable records of device quality assurance shall be maintained. Daily, monthly, and annual QA documentation for linear accelerators and CT Sim are accessible. |
| 100% of QA/QI documents complete in accordance with ACR. ASTRO & AAPM standards and reported as required to VA Radiation Oncology Service QA Committee. 100% of QA/QI documents complete in accordance with appropriate radiotherapy practice standards and reported as required to Tumor Board. |
| (90%) of QA/QI documents complete in accordance with ACR standards and reported as required to the VA Radiation Oncology Service QA Committee. |
| Periodic Inspection of QA/QI documents provided. |
| Radiation Safety Policy and Standards for Practice Accreditation |
| 4.6.9. |
| CTMP is responsible for the Radiation Safety Program (RSP) of the Radiation Oncology Service/Section. The RSP shall meet the accreditation standards of the Accreditation body. RSP shall meet the radiation safety standards, policies and procedures set by NRC, NHPP and relevant radiotherapy practice standards. The RSP status, to include the correction plan for all radiation safety related deficiencies noted by site surveys from accrediting body NHPP or Imaging and Radiation Oncology Core (IROC) shall be reported quarterly as a part of the quarterly medical physicist report to the James H. Quillen VAMC Radiation Safety Committee |
| All (100%) Radiation safety standards and external review requirements shall be met. Quality Management reports shall be submitted quarterly to the James H. Quillen VAMC Radiation Safety Committee. |
| 100% |
| Periodic Inspection |
| Medical Physics Reports demonstrate radiotherapy practice standards promulgated by ACR, ASTRO, and AAPM. |
| 4.6.10. |
| Contractor’s Therapeutic Medical Physicists shall develop and maintain a quality management program (QMP) for the dosimetry system(s) and all applications pertinent thereto. Said QMP shall define explicit evaluation criteria intended to ensure that the prescribed dose is delivered in a safe, consistent, and accurate manner. Contractor shall provide the VA Radiation Oncology Service, with written reports of these activities. Quality management of radiation therapy equipment is primarily an ongoing evaluation of functional performance characteristics. |
All (100%) of required medical physicist reports documenting the successful evaluation of equipment performance (meeting or exceeding relevant radiotherapy practice standards) to include therapy machines, radiation sources, and CT simulators for proper working order is required. All external review requirements per relevant radiotherapy practice standards are met, including those of TJC.
| 95% |
| Periodic Inspection of Documents |
7. RATINGS
Metrics and methods are designed to determine rating for a given standard and acceptable quality level. The following ratings shall be used:
| EXCEPTIONAL: |
| Contractor always meets the standard. Performance meets contractual requirements and exceeds many to the Government’s benefit. The contractual performance of the element or sub-element being assessed was accomplished with few minor problems for which corrective actions taken by the contractor were highly effective. |
Note: To justify an Exceptional rating, you should identify multiple significant events in each category and state how it was a benefit to the GOVERNMENT. However, a singular event could be of such magnitude that it alone constitutes an Exceptional rating. Also, there should have been NO significant weaknesses identified.
| VERY GOOD: |
| Contractor almost always meets the standard, always performs over the Acceptable Quality Level. Performance meets contractual requirements and exceeds some to the Government’s benefit. The contractual performance of the element or sub-element being assessed was accomplished with some minor problems for which corrective actions taken by the contractor were effective. |
Note: To justify a Very Good rating, you should identify a significant event in each category and state how it was a benefit to the GOVERNMENT. Also, there should have been NO significant weaknesses identified.
| SATISFACTORY: |
| Contractor occasionally meets the standard, but more often meets the Acceptable Quality Level. Performance meets contractual requirements. The contractual performance of the element or sub-element contains some minor problems for which corrective actions taken by the contractor appear or were satisfactory. |
Note: To justify a Satisfactory rating, there should have been only minor problems, or major problems the contractor recovered from without impact to the contract. Also, there should have been NO significant weaknesses identified.
| MARGINAL: | |
| Contractor most often meets the Acceptable Quality Level, occasionally does not meet the Acceptable Quality Level and CDRs have been reported. Performance does not meet some contractual requirements. The contractual performance of the element or sub-element being assessed reflects a serious problem for which the contractor has not yet identified corrective actions. The contractor’s proposed actions appear only marginally effective or were not fully implemented. | |
| Note: To justify Marginal performance, you should identify a significant event in each category that the contractor had trouble overcoming and state how it impacted the GOVERNMENT. A Marginal rating should be supported by referencing the management tool that notified the contractor of the | contractual deficiency (e.g. Management, Quality, Safety or Environmental Deficiency Report or letter). |
| UNSATISFACTORY: |
| Contractor has history of not meeting Acceptable Quality Level. Significant efforts have been made to bring Contractor into performance. Performance does not meet most contractual requirements and recovery is not likely in a timely manner. The contractual performance of the element or sub-element being assessed contains serious problem(s) for which the contractor’s corrective actions appear or were ineffective. |
Note: To justify an Unsatisfactory rating, you should identify multiple significant events in each category that the contractor had trouble overcoming and state how it impacted the GOVERNMENT. However, a singular problem could be of such serious magnitude that it alone constitutes an unsatisfactory rating. An Unsatisfactory rating should be supported by referencing the management tools used to notify the contractor of the contractual deficiencies (e.g., Management, Quality, Safety or Environmental Deficiency Reports, or letters).
| 8. | DOCUMENTING PERFORMANCE |
| a. | The Government shall document positive and/or negative performance. Any report may become a part of the supporting documentation for any contractual action and preparing annual past performance using CONTRACTOR PERFORMANCE ASSESSMENT REPORT (CPAR). |
| b. | If contractor performance does not meet the Acceptable Quality level, the CO shall inform the contractor. This will normally be in writing unless circumstances necessitate verbal communication. In any case the CO shall document the discussion and place it in the contract file. When the COR and the CO determines formal written communication is required, the COR shall prepare a Contract Discrepancy Report (CDR), and present it to CO. The CO will in turn review and will present to the contractor's program manager for corrective action. |
The contractor shall acknowledge receipt of the CDR in writing. The CDR will specify if the contractor is required to prepare a corrective action plan to document how the contractor shall correct the unacceptable performance and avoid a recurrence. The CDR will also state how long after receipt the contractor must present this corrective action plan to the CO. The Government shall review the contractor's corrective action plan to determine acceptability. The CO shall also assure that the contractor receives impartial, fair, and equitable treatment. The CO is ultimately responsible for the final determination of the adequacy of the contractor’s performance and the acceptability of the Contractor’s corrective action plan.
Any CDRs may become a part of the supporting documentation for any contractual action deemed necessary by the CO.
| 9. | FREQUENCY OF MEASUREMENT | |
| a. | Frequency of Measurement. |
The frequency of measurement is defined in the contract or otherwise in this document. The government (COR or CO) will periodically analyze whether the frequency of surveillance is appropriate for the work being performed.
b. Frequency of Performance Reporting.
The COR shall communicate with the Contractor and will provide written reports to the Contracting Officer quarterly (or as outlined in the contract or COR delegation) to review Contractor performance.
10. COR AND CONTRACTOR ACKNOWLEDGEMENT OF QASP
SIGNED:
JASON DUBAY, Supervisory Radiation Therapist DATE
SIGNED:
CONTRACTOR NAME/TITLE DATE
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